NCT02545634

Brief Summary

The study will examine the effect of a probiotic supplement (Lactobacillus helveticus R0052 and Bifidobacterium Longum R0175) dissolved in a dairy product such as milk or ice-cream on symptoms of ADHD and anxiety in children. The main goal is to determine if probiotics might be useful as a treatment for anxiety and ADHD symptoms in children. A second goal is to examine the effects of probiotics on saliva cortisol levels. Finally, the investigators are also interested in the effects of the probiotics on children's digestive health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 30, 2015

Last Update Submit

September 8, 2015

Conditions

Attention Deficit Hyperactivity DisorderAnxiety

Keywords

probioticADHDanxietydigestive healthchildrenattention deficitgut brain axisnutritional supplementmicrobiome

Outcome Measures

Primary Outcomes (1)

  • Change in ADHD-specific items of the Child Disruptive Behavior Disorders Scale

    First day of study participation and again at weeks 4, 8, and 12

Secondary Outcomes (5)

  • Change in Salivary cortisol

    First day of study participation and again at weeks 4, 8, and 12

  • Change in total score on the Screen for Child Anxiety Related Emotional Disorders

    First day of study participation and again at weeks 4, 8, and 12

  • Change in Word Pairs Memory Test

    First day of study participation and again at weeks 4, 8, and 12

  • Change in Visual Memory Test

    First day of study participation and again at weeks 4, 8, and 12

  • Change in total omission and commission errors on the Continuous Performance Task

    First day of study participation and again at weeks 4, 8, and 12

Study Arms (2)

Placebo powder

PLACEBO COMPARATOR

Placebo powder contains the same ingredients as the probiotic powder except the L. helveticus R0052 and B. longum R0175. All participants will consume the placebo for 28 days during one of two dosing phases.

Other: Placebo

Probiotic powder

EXPERIMENTAL

The Investigational Product is formulated with a combination of two active ingredients: L. helveticus R0052 and B. longum R0175 and the percentage of each strain is 90% and 10% respectively. The minimum total count of L. helveticus R0052 and B. longum R0175 is 3 x 109 colony forming units (CFU) per stick during the shelf-life. The IP also contains the following excipients: xylitol (sweetener), maltodextrin (coating agent), fruit flavor and malic acid (acidity regulator). The total weight is 1.5 g per stick. All participants will consume the placebo for 28 days during one of two dosing phases.

Dietary Supplement: L. helveticus R0052 and B. longum R0175

Interventions

L. helveticus R0052 and B. longum R0175DIETARY_SUPPLEMENT

See arm descriptions for intervention description.

Also known as: Probiostick, Jamieson Probiotic Sticks, Health Canada Natural Product Number (NPN) 80021343
Probiotic powder
PlaceboOTHER
Placebo powder

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • average score of 2.5 or higher on either the hyperactive/impulsive or inattentive symptoms on eligibility questionnaire
  • total score of 10 or higher on the anxiety eligibility questionnaire

You may not qualify if:

  • Dairy or Soy allergy
  • Currently taking antibiotics
  • HIV/AIDS
  • Diagnosis of Cancer, Crohn's Disease, or Ulcerative Colitis
  • Undergoing chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acadia University

Wolfville, Nova Scotia, B4P 2R6, Canada

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAnxiety Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Potter, Phd.

    Acadia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Potter, Phd.

CONTACT

902-585-1220susan.potter@acadiau.ca

Patrick Bazinet, BAh

CONTACT

9027903548bazinet.patrick@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

September 10, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

CA(1)